The objectives of this study are to evaluate the efficacy and safety of quetiapine extended release tablet versus placebo as adjunct to selective serotonin reuptake inhibitors/serotonin/norepinephrine reuptake inhibitors (SSRI/SNRI) in the augmentation treatment of patient with primary anxiety disorders or mood disorders with co-morbid anxiety symptoms.

Quetiapine orally at a flexible dose fo 50-300mg/day according to the judgment by the investigator for 8 weeks, as adjunct to the same antidepressant at the same dose.

Drug: Quetiapine extended release tablet

Quetiapine extended release tablet of 50-300mg/day

Placebo Comparator: Placebo

Placebo orally, as adjunct to the same antidepressant at the same dose.

Drug: Placebo

Placebo orally, as adjunct to the same antidepressant at the same dose.

Eligibility

Ages Eligible for Study:

18 Years to 65 Years (Adult)

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Provision of written informed consent

A diagnosis of primary anxiety disorder or mood disorder with co-morbid anxiety symptoms by Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition (DSM-IV)

A 14-item Hamilton Anxiety Scale (HAM-A)>= 14

Subject have received single antidepressant at a therapeutic dose for at least 6 weeks

Male or female aged 18-65 years

Female patients of childbearing potential must be using a reliable method of contraception and have a negative urine human chorionic gonadotropin (HCG) test at enrollment

Able to understand and comply with the requirements of the study and sign informed consent

Exclusion Criteria:

Pregnancy or lactation

Any DSM-IV Axis I disorder not defined in the inclusion criteria.

Receiving any anti-psychotic 7 days prior to entering the study

Patients who, in the opinion of the investigator, post an imminent risk of suicide or a danger to self or others

Known intolerance or lack of response to quetiapine fumarate, as judged by the investigator

Use of any of the following cytochrome P450 3A4 inhibitors in the 14 days preceding enrollment including but not limited to: ketoconazole, itraconazole, fluconazole, erythromycin, clarithromycin, troleandomycin, indinavir, nelfinavir, ritonavir, fluvoxamine and saquinavir

Use of any of the following cytochrome P450 3A4 inducers in the 14 days preceding enrollment including but not limited to: phenytoin, carbamazepine, barbiturates, rifampin, St.John's Wort, and glucocorticoids

Administration of a depot antipsychotic injection within one dosing interval (for the depot) before randomization

Substance or alcohol dependence at enrollment (except dependence in full remission, and except for caffeine or nicotine dependence), as defined by DSM-IV criteria

Admitted to hospital for treatment of DM or DM related illness in past 12 weeks.

Not under physician care for DM

Physician responsible for patient's DM care has not indicated that patient's DM is controlled

Physician responsible for patient's DM care has not approved patient's participation in the study

Has not been on the same dose of oral hypoglycaemic drug(S) and/or diet for the 4 weeks prior to randomization. For thiazolidinediones(glitazones) this period should not be less than 8 weeks

Taking insulin whose daily dose on one occasion in the past 4 weeks has been more than 10% above or below their mean dose in the preceding 4 weeks

An absolute neutrophil count (ANC) of <= 1.5x10(9) per liter

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00912535